PerkinElmer, Inc.,
a global leader focused on improving the health and safety of people and the
environment, today announced that it has opened a second specialized Good Manufacturing
Practice* (GMP) services facility. The Company has added this capability in
response to expanded demand for custom radiosynthesis of potential drug compounds
for ADME (Absorption, Distribution, Metabolism and Excretion) research studies.
PerkinElmer's GMP Radiosynthesis Services provide advanced expertise for the
manufacture and synthesis of radiolabeled compounds to help pharmaceutical,
biotechnology and contract research organizations (CROs) accelerate drug development.
The addition of a second facility demonstrates the Company’s continuing
commitment to providing the highest quality products and services to research
communities. PerkinElmer inaugurated its first GMP compliant facility in late
2008 in Boston, and has now doubled its capacity for GMP based services, due
to increased client uptake throughout 2009.
Richard M. Eglen, Ph.D., president, Bio-discovery, PerkinElmer, Inc., said,
"PerkinElmer is pleased to announce this expansion of our GMP facilities
to better serve our clients, through advanced services designed to improve and
enhance studies of potential drug compounds. Radiolabeling of new drug candidates
for ADME is a major tool that assists drug discovery researchers to better understand
the distribution of the compound as it moves through the body."
He added, "With the cost of drug development remaining high, and the costs
of potential failures further down the research pipeline growing, PerkinElmer
is responding to increased pharma demand for stronger early indicators of potential
success or failure to make better decisions regarding project advancement."
PerkinElmer's GMP Radiosynthesis Services support team leverages more than
five decades of radioactive materials expertise as well as exacting regulatory
and documentation compliance, along with a vast compound catalog for screening
experimentation. PerkinElmer is a premier manufacturer of custom GMP radiolabeled
compounds. Compounds are routinely 98-plus percent pure, and are provided with
the goal of achieving 100 percent on-time delivery.
PerkinElmer's GMP Custom Radiosynthesis Services include:
- GMP synthesis for Phase I studies
- Non-GMP synthesis for preclinical animal studies
- Radiochemical stability testing
- Special packaging using NRC-approved PerkinElmer materials
- Analytical services
- Worldwide shipping
* GMP consistent with ICH Q7, Good Manufacturing Practice Guidance for Active
Pharmaceutical Ingredients, August, 2001, Section 19, API's for Use in Clinical
Trials.
Posted August 24th, 2009
